Medical Lab technician hold sample blood for testing
Credit: Douglas Sacha/Getty Images

Mercy BioAnalytics, the developer of an early cancer detection liquid biopsy leveraging extracellular vesicles, has closed a $41 million Series A financing round that will be used to further the development of the company’s novel Mercy Halo test for high-risk lung cancer screening. The financing was led by Novalis LifeSciences, with participation from Sozo Ventures, Hatteras Venture Partners, iSelect Fund, American Cancer Society BrightEdge, and Broadway Angels, an all-women venture capital group. Additional strategic investments were made by Bruker and Labcorp.

“Cancer remains a leading cause of death globally, and liquid biopsy-based screening represents a meaningful opportunity to address barriers that contribute to disparities in early cancer detection, including in medically underserved populations said Dawn Mattoon, PhD, CEO of Mercy BioAnalytics. “We believe the Mercy Halo testing platform is uniquely capable of delivering high-performing, broadly accessible cancer screening across all communities. A simple, inexpensive blood-based screening test could be a vital new tool to significantly increase patient engagement in lung cancer screening, creating the opportunity to save lives through early detection.”

The testing platform behind Mercy Halo detects the presence of cancer via the simultaneous detection of multiple cancer-related biomarkers found on the surfaces of tumor-derived extracellular vesicles. The initial focus for Mercy BioAnalytics will be continued development of the platform for its leading program in lung cancer, due to the high unmet need. The American Cancer Society estimates there will be more than 127,000 deaths from lung cancer in the U.S. alone this year, making it the leading cause of cancer mortality.

In addition to continuing the development of Mercy Halo, the company also intends to develop the test for other indications, including ovarian cancer which is not diagnosed until Stage III or Stage IV in 80% of the cases, which leads to poor long-term survival rates. Over time, Mercy will develop a broad test menu for the Mercy Halo platform across a range of cancer indications.

Last year, at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, Mercy presented preliminary data demonstrating that its Mercy Halo Ovarian Cancer assay outperformed the CA 125 test in distinguishing early-stage high-grade serious ovarian cancer (HGSOC) from women with benign conditions. Specifically the study found the assay:

  • Displayed separation of HGSOC from benign adnexal masses and healthy controls that was superior to CA125;
  • When run against a variety of off-target cancers and inflammatory conditions, in most instances, discriminated them from ovarian cancer; and
  • When run in paired serum and plasma samples, had highly correlated signals with virtually no bias, indicating the assay can be validated further in established blood biorepositories, which offers the potential to accelerate clinical study and development.

The company says that its ovarian cancer test will perform better than the current standard of care of the CA 125 test and ultrasound. It also has an advantage over the use of circulating tumor DNA (ctDNA), which is not found in abundance in the bloodstream in early cancers and also not readily obtained by tumors that are not well vascularized. Mercy Halo overcomes this by detecting co-localized biomarkers on the surfaces of cellular vesicles which are found in abundance in the blood stream.

“Liquid biopsy is an important advance in clinical testing that has not yet been fully realized” said Paul Meister, partner at Novalis LifeSciences, and member of Mercy’s board of directors. “Mercy is taking a unique approach designed to address the challenges that have plagued early cancer detection liquid biopsy tests that seek to measure tumor-derived DNA. We have been impressed with Mercy’s early clinical data, their relentless focus on scientific rigor, and thoughtful approach to commercialization. We are excited to partner with the company to further validate their Mercy Halo test portfolio across the most challenging cancers we face.”

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